spf15 lip balm

spf15 lip balm
SPL v5
SPL
SPL Set ID 2bb9798f-36a0-4d03-a316-8b746a9283d8
Route
topical
Published
Effective Date 2024-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (20 mg) homosalate (80 mg) octocrylene (55 mg) octisalate
Inactive Ingredients
mineral oil ceresin coconut oil ethylhexyl palmitate high density polyethylene tridecyl trimellitate shea butter butylated hydroxytoluene .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-06-01
Purpose

Sunscreen

Description

Avobenzone 2% Octocrylene 8% Octisalate 5.5% Homosalate 2%

Medication Information

Warnings

For external use only.

Uses
  • Helps prevent sunburn.
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Usa a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: Ask a doctor.
Other Information
  • Protect from excessive heat and direct sun.
Inactive Ingredients

Mineral Oil, Ozokerite, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridencyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.

Description

Avobenzone 2% Octocrylene 8% Octisalate 5.5% Homosalate 2%

Questions?

Call AP Specialties 

BATCH NO:

Distributed by:

Do Not Use 

on damaged or broken skin.

Package Labeling:

Active Ingredients

Avobenzone 2% Octocrylene 8% Octisalate 5.5% Homosalate 2%





When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor 

if reash occurs.

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control right away.

Package Labeling: 70412 316 09

Structured Label Content

Warnings

For external use only.

Uses
  • Helps prevent sunburn.
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Usa a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: Ask a doctor.
Other Information
  • Protect from excessive heat and direct sun.
Inactive Ingredients

Mineral Oil, Ozokerite, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridencyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.

Questions?

Call AP Specialties 

BATCH NO:

Distributed by:

Do Not Use  (Do not use )

on damaged or broken skin.

Package Labeling:

Active Ingredients

Avobenzone 2% Octocrylene 8% Octisalate 5.5% Homosalate 2%





When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor  (Stop use and ask a doctor )

if reash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control right away.

Package Labeling: 70412 316 09 (Package Labeling: 70412-316-09)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:29.074828 · Updated: 2026-03-14T23:03:32.552873